Major Depressive Disorder (MDD)CLEOPATRANCT07862205
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
A study testing MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG in people with Major Depressive Disorder (MDD) and Treatment Resistant Depression, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive… Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Treatment Resistant Depression, Major Depression
- What is being tested?
- MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients
- Voluntary patient seeking treatment with the capacity to consent
- 22-60 years of age
- Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57
- Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable
- Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS
Show all 14Show fewer
- In a current episode of MDD with duration of at least 4 weeks but less than 2 years
- Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening
- Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire
- On a medically acceptable form of birth control if capable of becoming pregnant
- Are able to adhere to the protocol and treatment schedule
- Currently and throughout study participation is under the care of a licensed psychiatrist and/or other mental health care provider and agrees to promptly inform the investigator or study staff of any change in such provider(s).
- Agrees to allow any and all forms of communication between the investigators and study staff with any healthcare provider who has provided service to the patient/participant within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
- Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within reasonable driving time of the patient's home address. Participant also agrees that research personnel are at liberty to contact these individuals if the participant is unable to be contacted.
Who cannot join
- Have a history of a substance use disorder (including alcohol)
- Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., "non-idiopathic"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps
- Contraindications for TMS or MRI
- Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.
- Pregnant and lactating patients
- As determined by the Principal Investigator (PI), has: (a) a lifetime history of mania or hypomania symptoms from any cause; (b) a medical condition or diagnosis, within 1 year of screening, that seems somewhat likely to cause such symptoms; or (c) scores 12 on the Young Mania Rating Scale.
- Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms.
- Patients taking bupropion/Wellbutrin or antipsychotics are excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Courtney Caves, 507-255-0624, CLEOPATRA@mayo.edu
Sarah Purdy, 507-266-3303, CLEOPATRA@mayo.edu
About this study
Official title: Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder
The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD).
This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.
Read the detailed description
This is a randomized, double-blind, 3 arm trial with a parallel design. All patients will receive an FDA cleared form of TMS called intermittent theta burst (iTBS) but will be randomized to 1) Closed-loop TMS-EEG with stimulation bursts delivered at the trough of theta waves, 2) Closed- loop TMS-EEG with stimulation bursts delivered at the peak of theta waves or 3) Closed-loop TMS-EEG random phase TMS delivery (control stimulation). Patients in all 3 study arms will wear EEG caps and undergo similar procedures to facilitate blinding. Blinded clinical raters will collect depression symptom severity measures at screening, baseline, and weekly for 6 weeks followed by monthly follow-up visits for 3 months to assess for delayed responses to treatment. The iTBS will be delivered with a MagVenture Cool B70 coil and X100 stimulator. TBS treatment will be delivered once daily (5 days per week for 6 weeks) to the left DLPFC at 120% MT, 600 pulses per session. The Localite system will provide neuronavigation for treatment site localization with the participant's structural MRI or in patients that cannot obtain an MRI, the provided standard MNI atlas. Depressive symptom severity will be assessed weekly with the 17-item Hamilton Depression Rating Scale (HDRS), the Montgomery-Asberg Depression Rating Scale (MADRS), a patient-reported Patient Health Questionnaire (PHQ-9)55, and a Generalized Anxiety Disorder 7-time scale (GAD-7)56. Patients will continue to receive any standard clinical psychotherapy at the same frequency and will continue current psychotropic medications at the current dose consistently for the duration of the study. Clinical assessments visits will take place during the last treatment day (treatment 5) of every week for 6 weeks of treatment. Follow-up assessments will be collected in person or remotely (via zoom or telephone appointment) based on patient preference.
- Being tested
- MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG
- Keywords
- Transcranial Magnetic Stimulation (TMS), Major Depressive Disorder, Intermittent Theta Burst Stimulation (iTBS), Adults with MDD
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEGDevice
The MagVenture TMS Therapy System is based on the use of intermittent theta burst stimulation, or iTBS. This novel TMS protocol delivers treatment in only 3 minutes and is based on a patterned TMS paradigm delivered to the left-dorsolateral prefrontal cortex (LDPFC) at 120% of resting motor threshold (MT). It consists of bursts of 3 pulses at 50 Hz, with bursts repeated at 5 Hz, in a duty cycle of 2s on, 8 s off, over 3 minutes and 9 seconds, and a total of 600 pulses.
For peak or trough iTBS, stimulation will consist of 3 pulses at 50 Hz delivered at intervals of their individual theta rhythm (e.g. 200 msec for a 5Hz oscillation) followed by an 8 second rest period. The pulses will be aligned to either the peak or the trough of the theta rhythm at the beginning of each pulse train. The TMS therapy will be delivered to the Left DLPFC at 120% of resting motor threshold (MT) daily for 5 days per week, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peak Theta Closed-Loop iTBS | Experimental | Participants receive EEG-guided intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex (DLPFC). Stimulation bursts are synchronized to the peak of the participant's individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). Receives: Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG |
| Trough Theta Closed-Loop iTBS | Experimental | Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation bursts synchronized to the trough of individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total) Receives: Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG |
| Random Phase iTBS | Active comparator | Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation occurring at a random phase of theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). This arm serves as the reference condition. Receives: Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of closed-loop EEG guided iTBS in adult participants with MDD.
Participant retention and completion rate of 80% or more at 4 and 6 weeks of treatment in patients receiving closed-loop guided iTBS
Measured: 6 weeks and 12 weeks post-treatment
Secondary outcomes (1)
Change in Hamilton Depression Rating Scale (HDRS-17)
Closed-loop iTBS delivered to the peak theta rhythm will have greater improvements in depressive symptom severity as assessed with the HDRS as compared to the participants in the trough (n=20) and random (n=20) delivered iTBS.
Measured: Baseline through Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blind Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Paul E. Croarkin, Mayo Clinic
- Investigators
- Paul E Croarkin, DO, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862205
- Sponsor's protocol ID
- 23-007582
- Acronym
- CLEOPATRA
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) collected during this study will not be made publicly available.
Publications
Shirinpour S, Alekseichuk I, Mantell K, Opitz A. Experimental evaluation of methods for real-time EEG phase-specific transcranial magnetic stimulation. J Neural Eng. 2020 Jul 13;17(4):046002. doi: 10.1088/1741-2552/ab9dba.
PubMed 32554882Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.
PubMed 29274805Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
PubMed 32252538Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15.
PubMed 30764649Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07862205
- Acronym / sponsor ID
- CLEOPATRA / 23-007582
- Keywords
- Transcranial Magnetic Stimulation (TMS), Major Depressive Disorder, Intermittent Theta Burst Stimulation (iTBS), Adults with MDD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD).
This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.
Detailed description
This is a randomized, double-blind, 3 arm trial with a parallel design. All patients will receive an FDA cleared form of TMS called intermittent theta burst (iTBS) but will be randomized to 1) Closed-loop TMS-EEG with stimulation bursts delivered at the trough of theta waves, 2) Closed- loop TMS-EEG with stimulation bursts delivered at the peak of theta waves or 3) Closed-loop TMS-EEG random phase TMS delivery (control stimulation). Patients in all 3 study arms will wear EEG caps and undergo similar procedures to facilitate blinding. Blinded clinical raters will collect depression symptom severity measures at screening, baseline, and weekly for 6 weeks followed by monthly follow-up visits for 3 months to assess for delayed responses to treatment. The iTBS will be delivered with a MagVenture Cool B70 coil and X100 stimulator. TBS treatment will be delivered once daily (5 days per week for 6 weeks) to the left DLPFC at 120% MT, 600 pulses per session. The Localite system will provide neuronavigation for treatment site localization with the participant's structural MRI or in patients that cannot obtain an MRI, the provided standard MNI atlas. Depressive symptom severity will be assessed weekly with the 17-item Hamilton Depression Rating Scale (HDRS), the Montgomery-Asberg Depression Rating Scale (MADRS), a patient-reported Patient Health Questionnaire (PHQ-9)55, and a Generalized Anxiety Disorder 7-time scale (GAD-7)56. Patients will continue to receive any standard clinical psychotherapy at the same frequency and will continue current psychotropic medications at the current dose consistently for the duration of the study. Clinical assessments visits will take place during the last treatment day (treatment 5) of every week for 6 weeks of treatment. Follow-up assessments will be collected in person or remotely (via zoom or telephone appointment) based on patient preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Double Blind Trial
| Arm | Type | Receives |
|---|---|---|
| Peak Theta Closed-Loop iTBS | Experimental | Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEGParticipants receive EEG-guided intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex (DLPFC). Stimulation bursts are synchronized to the peak of the participant's individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). |
| Trough Theta Closed-Loop iTBS | Experimental | Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEGParticipants receive EEG-guided iTBS delivered to the left DLPFC with stimulation bursts synchronized to the trough of individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total) |
| Random Phase iTBS | Active comparator | Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEGParticipants receive EEG-guided iTBS delivered to the left DLPFC with stimulation occurring at a random phase of theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). This arm serves as the reference condition. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Outpatients
- Voluntary patient seeking treatment with the capacity to consent
- 22-60 years of age
- Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57
- Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable
Key exclusion criteria (8 listed)
- Have a history of a substance use disorder (including alcohol)
- Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., "non-idiopathic"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps
- Contraindications for TMS or MRI
- Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.
- Pregnant and lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEGThe MagVenture TMS Therapy System is based on the use of intermittent theta burst stimulation, or iTBS. This novel TMS protocol delivers treatment in only 3 minutes and is based on a patterned TMS paradigm delivered to the left-dorsolateral prefrontal cortex (LDPFC) at 120% of resting motor threshold (MT). It consists of bursts of 3 pulses at 50 Hz, with bursts repeated at 5 Hz, in a duty cycle of 2s on, 8 s off, over 3 minutes and 9 seconds, and a total of 600 pulses. For peak or trough iTBS, stimulation will consist of 3 pulses at 50 Hz delivered at intervals of their individual theta rhythm (e.g. 200 msec for a 5Hz oscillation) followed by an 8 second rest period. The pulses will be aligned to either the peak or the trough of the theta rhythm at the beginning of each pulse train. The TMS therapy will be delivered to the Left DLPFC at 120% of resting motor threshold (MT) daily for 5 days per week, for 6 weeks. | Device | Peak Theta Closed-Loop iTBS, Random Phase iTBS, Trough Theta Closed-Loop iTBS |
Primary outcome
Feasibility of closed-loop EEG guided iTBS in adult participants with MDD.
Time frame: 6 weeks and 12 weeks post-treatment
Participant retention and completion rate of 80% or more at 4 and 6 weeks of treatment in patients receiving closed-loop guided iTBS
1 secondary outcome
Change in Hamilton Depression Rating Scale (HDRS-17)
Time frame: Baseline through Week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 32554882Shirinpour S, Alekseichuk I, Mantell K, Opitz A. Experimental evaluation of methods for real-time EEG phase-specific transcranial magnetic stimulation. J Neural Eng. 2020 Jul 13;17(4):046002. doi: 10.1088/1741-2552/ab9dba.
- Background: PubMed 29274805Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.
- Background: PubMed 32252538Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
- Background: PubMed 30764649Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15.
- Background: PubMed 29726344Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this study will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul E Croarkin, DO, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG in people with Major Depressive Disorder (MDD) and Treatment Resistant Depression, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Caves (507-255-0624, wolf.courtney@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of closed-loop EEG guided iTBS in adult participants with MDD. (time frame: 6 weeks and 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862205, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.